Oliceridine-Enhanced Analgesia and Recovery: A G-Protein Biased μ-Opioid Study

NCT06409689 · tracked via the Priya Life Science China tracker

Sponsor

Tongji Hospital

Phase

Not applicable

Started

2024-06-01

Last updated

2025-01-03

Condition(s) studied

Postoperative Analgesia

Investigational drug(s) / intervention(s)

Oliceridine fumarate low doseOliceridine fumarate high doseOliceridine fumarate moderate dosemorphine

Oliceridine fumarate low dose: The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.1 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose

Oliceridine fumarate high dose: The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.5 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose

Oliceridine fumarate moderate dose: The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.35 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose

morphine: The first loading dose of morphine was 4 mg in all patients after operation. The PCA dose of the patients was 1 mg, and the locking interval was 6 min. A supplemental dose of 2 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 60 mg.

Study summary

Identifying the lowest effective opioid dose that achieves rapid pain relief while minimizing side effects is a principal objective in postoperative multimodal analgesia strategies. This study aims to determine the optimal analgesic regimen and dosage by assessing the clinical efficacy of oliceridine for postoperative pain management. It also evaluates oliceridine's contribution to accelerated postoperative recovery, examining aspects such as postoperative pulmonary complications, gastrointestinal function, nausea and vomiting, cognitive function, and emotional distress. Furthermore, the study integrates microbiomics and metabolomics to investigate the underlying molecular mechanisms by which oliceridine promotes rapid postoperative recovery. This research will broaden the clinical data and potential applications of oliceridine, addressing gaps in the field and enhancing practical knowledge. Moreover, this is the first time a clinical study combining multiple omics approaches will provide a comprehensive theoretical foundation for its clinical benefits.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: 1. ASA grades 1-2 2. Age \> 18 years and \< 70 years 3. Laparoscopic upper abdominal surgery under general anesthesia is planned, and the operation time is not more than 4 hours 4. Voluntarily receive postoperative controlled intravenous analgesia 5. Subjects understand and can cooperate with this study 6. Subjects can provide and sign written informed consent prior to conducting investigation-related screening procedures Exclusion Criteria: 1. BMI\>30 kg/m2 or \< 19 kg/m2 2. Patients with preoperative use of opioids, acute and chronic pain or hyperalgesia 3. Patients with coronary atherosclerotic heart disease, significant ischemic heart disease, severe angina, heart failure, valvular disease or other heart disease 4. More severe hepatic and renal insufficiency 5. A history of mental illness or alcoholism 6. A history of alcohol or drug abuse 7. Combined with cranial pressure, intraocular pressure or glaucoma 8. Poorly controlled or untreated hypertension before surgery 9. Preeclampsia or eclampsia 10. Untreated and undertreated hyperthyroidism 11. Combined with autoimmune disease 12. Unable to use the numerical rating scale 13. History of chronic cough 14. Surgery is expected to take more than 4 hours Patients enrolled in other clinical trials within 3 months

Primary outcome measure(s)

postoperative pain score — 6 hour, 24hour, and 48 hour after surgery
The NRS Numerical Pain Evaluation Scale assessed postoperative pain status: no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10).

Trial sites (1)

Facility	City	Region	Status
Tongji Hospital	Wuhan	Hubei	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06409689 on ClinicalTrials.gov ↗ ← All trials in China